DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-20 are under examination.
Priority
2. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the Republic of Korea on September 29, 2022. It is noted, however, that applicant has not filed a certified copy of the KR10-2022-0162988 application as required by 37 CFR 1.55.
Claim Objections
3. Claim 8 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Instant claim 8 describes the two or more pieces of information in step (e) of claim 1. However, claim 1, in step (d), also provides the same description of the two or more pieces of information. Thus, claim 8 is a substantial duplicate of claim 1.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Instant claims 1, 4, 8, 19, and 20 recite the parenthetical term “(reads)”, “(regional mutation density, RMD)”, and/or “(mutation signature)”. It is unclear if the parenthetical terms are intended to be limitations. Clarification via clear claim language is required. Claims 2, 3, 5-7, and 9-18 are also rejected for depending from claim 1.
Claim Rejections - 35 USC § 101
5. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
6. Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 1-20 are directed to method of predicting cancer type. As described in Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 573 U.S._, 134 S. Cr. 2347, 110 U.S.P.Q.2d 1976 (2014), a two-step analysis is required in considering the patent eligibility of the claimed subject matter. The first step requires determining if the claimed subject matter is directed to a judicial exception. The instant claims require the aligning sequence information with a reference genome database, dividing the reference genome into predetermined bins, obtaining an output value by inputting the two or more pieces of information to an artificial intelligence model trained to perform cancer diagnosis and cancer type prediction and analyzing the same; determining whether the cancer develops by comparing the analyzed output value with a cut-off value; and predicting the cancer type through comparison of the output value. These steps are drawn to mental steps or a mathematical algorithm. Dependent claims 2-18 recite additional mathematical steps or mental steps. The courts have found mathematical algorithms to be drawn to the judicial exception of an abstract idea (In re Grams, 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)). Thus, the instant claims are drawn to a judicial exception.
This judicial exception is not integrated into a practical application. The instant claims do not recite an element that reflects an improvement in the functioning of a computer or other technology, an element that applies the judicial exception to effect a particular treatment, an element that implements the judicial exception with a particular machine, or an element that effects a transformation of a particular article to a different state or thing. The instant claims recite the step of obtaining a sequence information by extracting nucleic acids from a biological sample. However, this step is extra solution data gathering activity. The instant claims also recite the elements of a device, a computer-readable medium, and a processor. However, the instant claims do not recite structural limitations of these elements. The instant claims do not recite a particular machine and does not integrate the judicial exception into a practical application.
The second part of the analysis requires determining if the claims include additional elements that are sufficient to amount to significantly more than the judicial exception. The instant claims recite the additional elements of obtaining a sequence information by extracting nucleic acids from a biological sample. The step of obtaining sequence information is a well-understood, routine, and conventional data gathering step (MPEP §2106.05(d)(II)). The instant claims also recite the elements of a device, a computer-readable medium, and a processor. However, these elements are well-understood, conventional, and routine components of a computer (Specification, pages 40 and 41). Reciting such well-understood, routine, and conventional elements do not transform a judicial exception into patent eligible subject matter. In addition, the recitation of the specific types of data, to be used in the judicial exception, does not transform the abstract idea into a non-abstract idea. (See buySAFE, Inc. v Google, Inc. 765 F.3d 1350, 112 U.S.P.Q.2d 1093 (Fed.Cir.2014)). Furthermore, the elements taken as a combination are also well-understood, routine, and conventional, since the elements are merely gathering data for the judicial exception and a computer to implement the judicial exception. Thus, the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
7. Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim does not fall within at least one of the four categories of patent eligible subject matter, because the claim is drawn to a computer readable storage medium. A computer readable storage medium encompasses carrier waves. However, carrier waves are non-statutory per se. Thus, the instant claims are drawn to non-statutory subject matter.
Claim Rejections - 35 USC § 102
8. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 8-12, 15, 16, 18, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jiao et al. (“A Deep Learning System Accurately Classifies Primary and Metastatic Cancer using Passenger Mutation Patterns” Nature Communications (2020) Number 11, Article: 728).
Regarding claims 1, 8, 19, and 20, Jiao et al. teaches a method that includes obtaining sequence information by extracting nucleic acids from a biological sample (page 2, right column, first full paragraph); aligning the sequence information with a reference genome database (page 2, left column, beginning with “The PCAWG Consortium”); dividing the reference genome into predetermined bins (page 2, right column, bottom paragraph); obtaining two or more pieces of information (page 2, right column, bottom paragraph – page 3; page 4, right column); obtaining an output value of the two or more pieces of information by inputting the information to an artificial intelligence model trained to perform cancer diagnosis and cancer type prediction (page 4, right column; pages 6-8; page 10, left column); determining whether the cancer develops by comparing the analyzed output value with a cut-off value (page 4, right column; pages 6-8); predicting the cancer type through comparison of the output value (page 4, right column; pages 6-8). In addition, Jiao et al. teach using code to perform their method, which would require a device and computer readable medium (page 10, right column).
Regarding claim 2, Jiao et al. teach where the bins are in a size between 100 kb to 10 Mb (page 2, right column, bottom paragraph).
Regarding claim 3, Jiao et al. teach detecting single nucleotide variant by filtering and extraction (page 9, right column).
Regarding claim 4, Jiao et al. teach calculating the number of single nucleotide variants extracted for each of the bins (page 3, Table 2) and dividing the calculated number by a total number of variants followed by normalization (page 3, Table 2).
Regarding claim 9, Jiao et al. teach where the are two or more modules to analyze the input of the two or more pieces of information (page 4, right column).
Regarding claim 10, Jiao et al. teach using random forests and artificial neural networks (page 4, right column).
Regarding claim 11, Jiao et al. teach where the artificial intelligence model comprise and output module to output a final result value (pages 9 and 10).
Regarding claim 12, Jiao et al. teach where the result value is a sum (page 4, right column).
Regarding claim 15, Jiao et al. teach where the artificial neural network is a deep neural network (page 4, right column).
Regarding claim 16, Jiao et al. teach where the output value is a probability index (page 4, right column).
Regarding claim 18, Jiao et al. teach predicting the cancer type by the highest value among output result values (page 4, right column).
Double Patenting
9. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
10. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12,163,194. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 1-20 and the claims 1-12 of the U.S. Patent. The claims differ in that the claims of the U.S. Patent require all the limitations of the instant claims with additional limitations. Thus, the subject matter of the instant claims encompasses the subject matter of the U.S. Patent. The claims are not patentably distinct.
11. Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/822,233 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 1-20 and the claims 1-13 of the reference application. The claims differ in that the claims of the U.S. Patent require all the limitations of the instant claims with additional limitations. Thus, the subject matter of the instant claims encompasses the subject matter of the U.S. Patent. The claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 19/253,446 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 1-20 and the claims 1-16 of the reference application. The claims differ in that the claims of the U.S. Patent require all the limitations of the instant claims with additional limitations. Thus, the subject matter of the instant claims encompasses the subject matter of the U.S. Patent. The claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
13. Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-18 of copending Application No. 19/130,837 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 1-20 and the claims 2-18 of the reference application. The claims differ in that the claims of the U.S. Patent require all the limitations of the instant claims with additional limitations. Thus, the subject matter of the instant claims encompasses the subject matter of the U.S. Patent. The claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
14. Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/704,958 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 1-20 and the claims 1-17 of the reference application. The claims differ in that the claims of the U.S. Patent require all the limitations of the instant claims with additional limitations. Thus, the subject matter of the instant claims encompasses the subject matter of the U.S. Patent. The claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JERRY LIN whose telephone number is (571)272-2561. The examiner can normally be reached T-F 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached at (571) 272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JERRY LIN/Primary Examiner, Art Unit 1685
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